Use of additive manufacturing processes in the manufacture of custom orthoses

ABSTRACT

A method for manufacturing a custom orthosis, such as an ankle brace, includes use of scanning processes. A digital model of a surface may be applied to a digital orthosis model to define a custom digital orthosis model. The digital model and, thus, the custom digital orthosis model may include one or more standard features. The custom digital orthosis model may be used with an automated manufacturing process to make some or all of the custom orthosis. In some embodiments, additive manufacturing processes may be used to form a portion or all of the custom orthosis.

A claim for priority is hereby made pursuant to 35 U.S.C. §119(e) to theDec. 22, 2012 filing date of U.S. Provisional Patent Application No.61/745,557, titled USE OF ADDITIVE MANUFACTURING PROCESSES IN THEMANUFACTURE OF CUSTOM ORTHOSES (“the '557 Provisional Application”), andto the Mar. 15, 2013 filing date of U.S. Provisional Patent ApplicationNo. 61/800,582, also titled USE OF ADDITIVE MANUFACTURING PROCESSES INTHE MANUFACTURE OF CUSTOM ORTHOSES (“the '582 Provisional Application”).The entire disclosures of the '557 Provisional Application and the '582Provisional Application are hereby incorporated herein.

TECHNICAL FIELD

This disclosure relates generally to methods for manufacturing customorthoses, such as ankle braces and, more specifically, to use ofadditive manufacturing processes to manufacture custom orthoses. Inaddition, this disclosure relates to systems that employ scanning ordigitizing equipment and additive manufacturing equipment in themanufacture of custom orthoses, and to custom orthoses that include oneor more components that have been fabricated by additive manufacturingprocesses.

RELATED ART

Custom orthoses, such as braces (e.g., knee braces, ankle braces, etc.),are typically designed to specifically fit the individual for whom theyare customized. Customization of an orthosis may optimize the supportthat the orthosis provides to a body part, such as a joint, to which theorthosis has been fitted. In addition, custom orthoses are typicallymore comfortable than standard versions of the same types of orthoses,including sized orthoses.

Conventionally, custom orthoses have been made by casting a negativemold of the part of an individual's body that an orthosis is supposed tosupport. The negative mold is then sent to the orthosis manufacturer,who uses the negative mold to make a positive mold, which generallyserves as an accurate replica of the individual's body part. Dependingat least partially upon the type of orthosis being made, material may beadded to or removed from the positive mold. One or more customizedfeatures of the orthosis may then be made on the positive mold, often byhand. From the forgoing, it should be apparent that conventionalprocesses for making custom orthoses are labor intensive and timeconsuming.

U.S. Pat. No. 6,155,997 to Castro (hereinafter “Castro”) discloses animprovement upon the conventional process for making custom orthoses.Specifically, Castro discloses processes for making custom ankle braces.According to Castro, one enhancement to the conventional process formaking custom orthoses includes the application of instructions, in theform of readily recognizable symbols, to an inner surface of a negativemold. The instructions may be placed on the inner surface of thenegative mold by a person, such as a health care professional, who isprescribing the custom ankle brace. When the brace maker receives thenegative mold and uses it to create a positive mold, the instructivesymbols that were placed on the inner surface of the negative mold aretransferred to corresponding locations on an outer surface of thepositive mold. The brace maker may then follow the instructions conveyedby the symbols to define features (e.g., build them up on, removematerial from, etc.) the positive mold. Once the brace maker hasmodified the positive mold in accordance with the instructions conveyedby the symbols, he or she may use the positive mold to make a customankle brace. Like other parts of the process, custom ankle braces arealso usually made by hand.

Because conventional processes for making custom orthoses (e.g., customankle braces, customized portions of knee braces, etc.) may be verylabor-intensive, such processes, from casting of a negative mold tocompletion of the custom orthosis, typically take several weeks (e.g., amonth, etc.) to complete. Thus, an individual for whom the orthosis isbeing made, and who may rely on that orthosis, may have to live withoutthe orthosis for the same amount of time.

SUMMARY

A process for making a custom orthosis according to this disclosureincludes the generation of a three-dimensional digital model (e.g., acomputer-aided design (CAD) file, etc.) that represents a negative(e.g., a casting, etc.) of a body part for which the orthosis is beingmade. For the sake of simplicity, the three-dimensional digital modelmay also be referred to herein as a “digital negative model” or, evenmore simply, as a “negative model.” The negative model may serve as thebasis for a customized digital orthosis model, or a custom digitalorthosis model, which may be used in conjunction with an additivemanufacturing process to make the custom orthosis, or at least acustomized portion of the orthosis.

s used hereinafter, “custom orthosis” may refer to an orthosis that hasbeen customized for use with a body part of a particular individual, toa customized portion of an orthosis, or to an orthosis that includes acustomized feature. Similarly, the term “orthosis” may be used inreference to an entire orthosis, a part of an orthosis that is to becustomized, or to an orthosis and any part thereof that may becustomized.

The negative model may be generated by digitizing or scanning (e.g., athree-dimensional scan; a three-dimensional, multi-point analysis fromwhich a three-dimensional model may be extrapolated; a two-dimensionalscan that can be used to generate a three-dimensional model; etc.) ofthe body part for which the orthosis is being made. As used herein, theterms “scan,” “scanning” and “scanner” and similar terms relate totechniques for obtaining three or more data points from which a threethree-dimensional model may be generated, including scanning techniquesand digitizing techniques. Thus, the results of scanning a body part maybe used to generate a three-dimensional digital model of the body part,which is also referred to herein as a “body part digital model” or as a“body part model.” The body part model may then provide a basis forgeneration of a negative model, which comprises a digital negative modelof the body part, which serves as the basis for the contour of one ormore surfaces of an orthosis or another medical device.

In some embodiments where digitization or scanning is used to generate anegative model, a body part may be scanned while it is in two or morepositions. Such scanning, which is also referred to herein as “dynamicscanning,” may be accomplished by incrementally positioning the bodypart in the two or more positions. As an example, a foot, ankle and/orknee may be scanned while the body part is placed in two or morepositions that typically occur as a subject walks (e.g., heel strike,mid-gait, toe-off, etc.). A scan may then be obtained with the body partin each of the incremental positions. Alternatively, the body part maybe scanned and two or more images obtained during movement of the bodypart; for example, while the subject walks (e.g., through at least onecycle of heel strike, mid-gait and toe-off, etc.). A dynamic scan mayprovide information about how motion of an impaired (e.g., injured,defective, etc.) body part (i.e., unnatural motion) varies from naturalmotion for that body part. That information may be used to generate amodel for a custom orthosis that prevents, or blocks out, unnaturalmotion while allowing or, or even enabling, natural motion, whichfacilitates correction of the impairment to the body part.

Alternatively, a negative model may be generated from a negative mold ofthe body part (e.g., by scanning the negative mold, etc.). Inembodiments where a negative mold serves as the basis for thethree-dimensional digital model, the negative mold may be made by, or atleast ordered by, a health care professional. One or more readilyrecognizable, optionally standardized symbols or other indicia may beplaced at locations where the orthosis is to be modified (e.g., builtup, etc.) in a manner prescribed by the health care professionalordering the orthosis or other medical device. Those indicia may conveyinformation for subsequent use by an individual (manual) or computer(automated) while generating a digital orthosis model from data obtainedfrom the negative mold. Negative molds are particularly useful insituations in which a scanner is not readily available to the healthcare professional. In those situations, and under other circumstances,the negative mold may be sent to a facility, such as a custom orthosismanufacturer, where the negative mold can be scanned to generate thenegative model.

As another alternative, a positive physical model of a body part may beused as the basis for the negative model. The positive physical modelmay be made by any suitable technique. As an example, a negative mold ofthe body part may be made. The negative mold may then be used to formthe positive physical model. One or more readily recognizable,optionally standardized symbols or other indicia may be placed atlocations on the positive physical model where an orthosis made usingthe positive physical model is to be modified (e.g., built up, etc.) ina manner prescribed by the health care professional ordering theorthosis or other medical device. Once the positive physical model hasbeen made, it may be scanned. Data obtained from scanning the positivephysical model may then serve as a basis for the negative model. Anyindicia on the positive physical model may be transferred to thenegative model (e.g., for direction on subsequent modification to bemade to a digital orthosis model, etc.) or result in modification of thenegative model.

Regardless of how the negative model is obtained or generated, it may bedigitally applied to a digital orthosis model, which may define variousfeatures of the custom orthosis that will be made based on the negativemodel. Non-limiting examples of such features of the digital orthosismodel include, but are not limited to, the outer periphery of theorthosis, the general shape and/or contour of the orthosis, uncustomizedfeatures of the orthosis (e.g., outer surfaces that do not engage orcontact the body part, etc.) and connectors for coupling the orthosis ororthosis part to other elements, among other features. When features,such as surface contours, dimensional positioning of two or morefeatures of the body part with which the orthosis will be used and thelike, from the negative mold are applied to the digital orthosis model,a customized digital orthosis model, or a custom digital orthosis model,is created.

A negative model and/or a customized digital orthosis model may bemodified to accommodate one or more features of a custom orthosis thatwill be made on the basis of the orthosis model. As an example, one ormore portions of a surface of the negative model or customized digitalorthosis model may be recessed so that an orthosis or portion of anorthosis manufactured from the customized digital orthosis model canaccommodate one or more corresponding features (e.g., reinforcementelements, cushions or pads, etc.). As another example, one or moreportions of the surface of the negative model or the customized digitalorthosis model may be recessed to accommodate features of the body part,such as bony prominences, bony protrusions or the like. In yet anotherexample, one or more portions of the negative model or the customizeddigital orthosis model may be built up. By digitally building up one ormore portions of the negative model or the customized digital orthosismodel, the model may be modified to include one or more correspondingprotruding features of a custom orthosis. Such features may perform avariety of functions, including without limitation, supporting acorresponding portion of the body part, applying a desired amount ofpressure to a corresponding portion of the body part and/or facilitatingproper alignment of a custom orthosis with the body part, to identifyonly a few.

A surface of the negative model/customized digital orthosis model may bemodified to impart different regions of the surface and, optionally,different regions of a custom orthosis that is to be fabricated on thebasis of the negative model/customized digital orthosis model, withdifferent rigidities and/or flexibilities. Differences in the rigiditiesand/or flexibilities of different regions of a custom orthosis may beachieved by using materials of different hardnesses in different regionsof the custom orthosis (e.g., softer materials in more flexible regions,harder materials in more rigid regions, etc.).

Once the customized digital orthosis model has been generated and, ifdesired, modified, it may serve as the basis, or as a three-dimensionalblueprint, upon which additive manufacturing equipment relies to definea custom orthosis, or at least a customized portion of an orthosis.Generally, when operating under control of programming based on thecustomized digital orthosis model, the additive manufacturing equipmentmay manufacture the custom orthosis as a plurality of adjacent, adheredelements, or sections. The adjacent, adhered elements may be defined andassociated with one another in a manner that physically represents thecustomized digital orthosis model. More specifically, the differentelements of a custom orthosis that is made by an additive manufacturingprocess may comprise layers that are at least partially superimposedwith respect to one another.

A customized, form-fitting surface of a custom orthosis may have acontour that is defined by a plurality of adjacent, mutually adheredelements. In various embodiments, the adhered elements have dimensionsthat impart the finished product with a high degree of definition,including smooth surface contours. Adjacent adhered elements are alsopermitted to integrate with one another, which eliminates weak points inthe finished structure (e.g., discrete boundaries between adjacentelements, etc.) and strengthens it.

Further customization may be achieved when additive manufacturingprocesses are used that provide for the use of two or more materials(e.g., different materials; materials with different properties, such ashardness; etc.) to define different regions of each element (e.g.,layer, etc.). When such a process is used, one or more layers of acustom orthosis may include one or more rigid regions and one or moreflexible regions, thus imparting the custom orthosis with a tailoredpattern of rigid and flexible features. Without limiting the scope ofthis disclosure, rigid features may prevent unnatural motion (e.g.,excessive movement beyond a normal range of motion, etc.) while enablinga normal range of motion. More flexible features may provide for greaterfreedom of movement (e.g., for uninjured anatomical structures, forinjured anatomical structures of the body part that are experiencinglimited range of motion.

The custom orthosis resulting from an additive manufacturing process maythen be assembled with other components of the orthosis, if necessary,and used by the individual for whom it was made. The resulting customorthosis may have substantially the same properties as, or even improvedproperties over, a hand-made custom orthosis.

In addition to being useful for manufacturing customized portions oforthoses, techniques that incorporate teachings of this disclosure maybe applied to the fabricating of other types of medical devices. By wayof non-limiting example, the disclosed processes may be used tofabricate casts, including casts that enable use of a stabilized bodypart in water and, thus, from which water may be readily removed (i.e.,the stabilized body part may be readily dried).

A system that incorporates teachings of this disclosure may include aphysical model generation component and a custom orthosis manufacturingcomponent. The physical model generation component may be the office ofa health care provider who is prescribing and/or ordering a customorthosis for one of its patients. The physical model generationcomponent may ship the physical model to a remote custom orthosismanufacturing component. Once the remote custom orthosis manufacturingcomponent receives the physical model, it may manufacture the customorthosis in accordance with this disclosure within a day or two. Intotal, this type of system may enable the manufacture of custom orthoseswithin three days to five days.

Other aspects, as well as features and advantages of various aspects ofthe disclosed subject matter, will become apparent to those of ordinaryskill in the art through consideration of the ensuing description, theaccompanying drawings and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a schematic representation of an embodiment of a method forgenerating a digital negative model of a body part, which includesscanning the body part;

FIG. 2 is an impact curve obtained as a subject with an impaired footwalked on a treadmill;

FIG. 3 is an impact force diagram of the forces experienced by theimpaired foot as the subject walked on the treadmill;

FIG. 4 is a schematic representation of another embodiment of a methodfor generating a digital negative model of a body part, in which aphysical negative mold, or cast, is formed, then scanned;

FIG. 5 is a schematic representation of yet another embodiment of amethod for generating a digital negative model of a body part, in whicha mold, or cast, is formed, then used to form a positive physical model,which is then scanned;

FIG. 6 provides a representation of application of a digital negativemodel to an orthosis model to generate a customized digital orthosismodel;

FIG. 7 illustrates an embodiment of a process in which a customizeddigital orthosis model provides a pattern for fabrication of a customorthosis by way of an additive manufacturing process;

FIG. 8 illustrates an embodiment of a part of a custom orthosisfabricated in accordance with the method depicted by FIG. 7 andincluding at least one layer with at least one rigid region and at leastone flexible region, which define rigid and flexible regions of thepart; and

FIG. 9 shows an embodiment of a custom orthosis.

DETAILED DESCRIPTION

In various embodiments, processes for making custom orthoses aredisclosed and depicted. Although the disclosed embodiments relate to themanufacture of a custom foot bed for an ankle brace, processes thatincorporate teachings of this disclosure may also be used to fabricatefeatures of other types of orthoses that are custom-made for use with abody part of a particular individual, and in processes for making entireorthoses.

With reference to FIG. 1, an embodiment of a method for obtaining anegative model of a body part P—depicted as the sole of an individual'sfoot—is illustrated. In such a method, a scanner 10 that has beenconfigured to generate a three-dimensional digital representation of ascanned object may be used to generate a three-dimensional digitalrepresentation of the body part P. In some embodiments, the scanner 10may comprise a digitizer that operates based on a so-called “last,” orbasic, representation (e.g., based on common dimensions for a particulardemographic, etc.) of the body part being digitized. A digitizer mayinclude a probe, such as a faro arm, that obtains an outline of the bodypart at intermittent locations along the body part (e.g., everycentimeter, every inch, etc.). These outlines, which providecross-sections of the body part, may then be assembled, and datainterpolated therebetween to provide a three-dimensional model of thebody part. In other embodiments, the scanner 10 may comprise athree-dimensional scanner of a known type.

The scanner 10 may be configured to obtain a single image of the bodypart P, or it may be configured to obtain two or more images of the bodypart P in a corresponding number of positions. A scanner 10 that obtainsdata while a body part P remains stationary may be used for this purposeby positioning the body part P in a plurality of different,substantially stationary positions while the scanner 10 operates.Alternatively, the scanner 10 may be configured to obtain data on a bodypart P as the body part P is in motion (e.g., a foot, ankle and/or kneeas a subject walks or runs on a treadmill, etc.). Some specific, butnon-limiting embodiments of such a scanner include one or morefluoroscopes or similar devices that obtain multiple images duringmovement, motion capture equipment and the like. Of course, otherapparatuses that provide data that may be used to generate athree-dimensional model may also be employed as the scanner 10.

The scanner 10 may transmit data 12 obtained from scanning the body partP to a processing element 14, such as a computer processor. Theprocessing element 14, under control of one or more programs, maygenerate a digital, three-dimensional, negative model of the body partP, or “digital negative model” 16 or “negative model.” The digitalnegative model 16 may include data that represents one or more surfaces18 that are contoured and arranged complementarily to, or as negativesof, one or more corresponding surfaces of the body part P. The one ormore surfaces 18 of the digital negative model 16 may represent surfacecontours that will ultimately be included in a custom orthosis.

In embodiments where the data 12 obtained by the scanner 10 correspondsto two or more chronological positions of the body part P, the data 12may provide additional insight as to the specific anatomical cause orcauses of any impairment of the body part P. Such data may be comparedwith other data on the body part P. As a non-limiting example, data 12obtained during a plurality of scans of a foot in motion throughoutgait, which data corresponds to the anatomy of the foot throughout gait,may be compared with other data (e.g., an impact curve (see FIG. 2), animpact force diagram (see FIG. 3), etc.) obtained as the subject walksor runs. Abnormalities in such other data may be useful in identifying aspecific anatomical cause or causes of each abnormality. Each anatomicalcause may then be addressed while generating the digital negative model16. Accordingly, the digital negative model 16 may account for thedynamic range of the body part P.

As an alternative to directly scanning a body part P to generate adigital negative model 16, a digital negative model 16 may be obtainedfrom a physical negative model, or cast 26, of the body part P, asillustrated by FIG. 4. A variety of processes may be used to make one ormore physical negative models 22 of the body part P. Without limitation,such a method may include positioning a thin, form-fitting element 24over the body part P. A cast 26 (e.g., a plaster cast, a fiberglasscast, etc.) may then be built up on the form-fitting element 24 andaround the body part P in a manner that causes an inner surface 28 ofthe cast 26 to substantially assume the shape of the body part P. Insome embodiments, the cast 26 may be built up without deforming theshape of the body part P or any of its surfaces. Once the cast 26 hashardened, it may be removed (e.g., from the body part P, etc.).

Once the cast 26 has been removed from a body part for which anorthosis, such as an ankle brace, is being customized, the cast 26 mayfunction as a physical negative model 22 of the body part P. Morespecifically, the cast 26, as a physical negative model 22, in one ormore sections, may be scanned by a scanner 10 to obtain digital data 12representative of the cast 26, and that data 12 may be processed by aprocessing element 14, which may then generate a digital,three-dimensional negative model 16, or “digital negative model” 16 or“negative model,” of the body part P or portion thereof.

FIG. 5 is a schematic representation of a process in which a cast 26 ofa body part P is formed, as described in reference to FIG. 4, and thenthe cast 26 used to form a positive physical model 26+ of the body partP. The positive physical model 26+ may be formed by any suitable mannerknown in the art. Without limitation, a flowable, hardenable material 29(e.g., a liquid resin, plaster, etc.) may be introduced into a cavity 27of the cast 26. As the flowable, hardenable material 29 solidifies, itforms the positive physical model 26+, and the cast 26 may be removedfrom the positive physical model 26+. The positive physical model 26+may then be scanned, and the data 12 obtained from scanning may be usedto generate a digital negative model 16 of the body part P or a portionthereof.

In various embodiments, one or more symbols X may be used on a cast 26,a positive physical model 26+ and/or a digital negative model 16 toidentify regions of an orthosis that are to be modified in a manner thatdiffers from the contour of a portion of a body part P with which theorthosis is to be used. A symbol X may comprise a readily recognizable,even standardized, indicia that enables an individual (manually) or acomputer (automatically) to identify the manner (e.g., location(s),extent(s), etc.) in which an orthosis is to be modified (e.g., areasthat are to be built up, areas that are to be formed from a materialwith a hardness that differs from a hardness of a remainder of theorthosis, recessed areas, etc.). The modification that corresponds to aparticular symbol X may be transferred to the digital negative model 16for subsequent use, or the modification that corresponds to that symbolX may be incorporated into the digital negative model 16 (i.e., thedigital negative model 16 may be modified). The symbol X may signal toan individual that certain modifications are to be made to the digitalnegative model 16 or a customized digital orthosis model 40 (see FIG.6), and the individual may manually make a modification that correspondsto each symbol X. Alternatively, each symbol X may be configured to berecognized by a processing element that generates the digital negativemodel 16 or applies the digital negative model to a digital orthosismodel 30 (see FIG. 6), and the processing element may incorporate theappropriate modification into the digital negative model 16 or thecustomized digital orthosis model 40.

Turning now to FIG. 6, once a digital negative model 16 of anindividual's body part P has been generated (and regardless of themanner in which digital negative model 16 was generated), the digitalnegative model 16 may be applied to (e.g., overlaid with, etc.) adigital orthosis model 30 (e.g., by processing element 14, anotherprocessing element, etc.). The digital orthosis model 30 may include acustomizable portion 34, as well as standard features, such as an outerperiphery 35, one or more coupling elements 36 (e.g., hinge elements,etc.), one or more stiffening features 37 (e.g., the illustratedgussets, etc.), among other standard features.

In a specific embodiment, the digital negative model 16 may be appliedto the digital orthosis model 30 by identifying two or more features 17on the digital negative model 16 that correspond to predeterminedreference features 32 on a digital orthosis model 30. The correspondingfeatures 17 and 32 may then be aligned with one another, effectivelysuperimposing the digital negative model 16 over at least a customizableportion 34 of the digital orthosis model 30. Any data from the digitalnegative model 16 located outside the customizable portion 34 of thedigital orthosis model 30 may be discarded. The remaining data from thedigital negative model 16, including data representative of the one ormore surfaces 18 that complement, or are negatives, of surfaces of thebody part P for which a custom orthosis is being manufactured, may beapplied to the customizable portion 34 of the digital orthosis model 30(i.e., it may be incorporated into the digital orthosis model 30 todefine a customized digital orthosis model 40.

Once a customized digital orthosis model 40 has been generated, it maybe processed and used to form a custom orthosis 50 (FIG. 7) or at leasta portion of a custom orthosis 50. FIG. 7 schematically illustrates anembodiment of a method for manufacturing, or fabricating, a customorthosis 50 from a customized digital orthosis model 40. As an exampleof such a method, an additive manufacturing process, such as thateffected by the systems available from Objet Geometries, Ltd., ofRehovot, Israel, may be used fabricate some or all of the customorthosis 50 as a series of layers. When such a process is used, thecustomized digital orthosis model 40 may be separated into a pluralityof sections 42, such as slices or layers (e.g., the customized digitalorthosis model 40 may be converted from a CAD (Computer Aided Design)format to any suitable format, such as an STL (or .stl)(STereoLithography) format, etc.).

Each of the sections 42 of the customized digital orthosis model 40 maybe used by an additive manufacturing system 60 to define a correspondingsection 52 of a custom orthosis 50. More specifically, the additivemanufacturing system 60 may be used to fabricate the custom orthosis 50,as well as any contoured surfaces that are intended to fit to the form,or contour, of a body part P (FIGS. 1 and 4), one section 52 (e.g.,layer, etc.) at a time. As each section 52 is formed, the material fromwhich it is formed may cure or otherwise solidify. Once a section 52 hasat least partially solidified (e.g., before that section 52 has fullycured, etc.), a subsequent section 52′ may be formed adjacent to it(e.g., at least partially superimposed over it, etc.). The subsequentsection 52′ may be formed before the previously formed, adjacent section52 has fully cured, enabling at least some integration between theadjacent sections 52 and 52′, which may impart a custom orthosis 50 thatresults from such a process with substantially smooth surfaces, increasethe fracture resistance (and, optionally, the flexibility) of the customorthosis 50, increase the strength of the custom orthosis 50, otherwiseimprove the custom orthosis or provide any combination of the foregoing.Alternatively, one section 52 may substantially cure or fully curebefore the subsequent section 52′ is formed, resulting in a structurewith a discernable, discrete boundary between the adjacent sections 52and 52′. In either event, the resulting structure includes a pluralityof adjacent, mutually adhered sections 52 (e.g., a plurality of at leastpartially superimposed, mutually adhered layers, etc.). Such a processmay be used to form a customized portion of the custom orthosis 50, anentire part of the custom orthosis 50, or the entire custom orthosis 50.

When the additive manufacturing system 60 includes a so-called “3Dprinter,” such as that manufactured by Objet, and a polypropylene-likematerial, such as the DurusWhite™ material available from Objet, is usedto form at least a portion of the custom orthosis, each section 52(e.g., layer, etc.) may have a thickness of about 0.005 inch to about0.001 inch or less. The smoothness of the surfaces of the customorthosis 50 corresponds, at least in part, to the thinness of thesections 52 from which the custom orthosis 50 is formed, with thinnersections 52 forming smoother surfaces.

In some embodiments, two or more materials may be co-deposited (e.g., aspart of the same section 52 (e.g. layer, etc.), as different sections 52(e.g. layers, etc.), as combinations of the foregoing, etc.) to form atleast part of a custom orthosis 50. As an example, a majority of thecustom orthosis 50 may be fabricated from a material that imparts thecustom orthosis 50 with one or more desired characteristics (e.g.,rigidity, durability, etc.), while another material may form a coatingon at least part of the custom orthosis 50 to provide it with addedcharacteristics (e.g., flexibility, cushioning, etc.). FIG. 8 shows aspecific embodiment of part of a custom orthosis 50 (FIG. 7) in whicheach of one or more sections 52 (FIG. 7) (e.g., a layer that forms asurface of the part, a plurality of layers adjacent to a surface of thepart, etc.) is defined from two or more materials with differentcharacteristics. More specifically, FIG. 8 illustrates an embodiment ofa foot bed 51 of a custom orthosis 50, with a rigid region 51R and aplurality of flexible regions 51F. More specifically, the rigid region51R may be defined by a material having a hardness of about 90 Shore Aor greater durometer, while each flexible region 51F may have a hardnessof about 30 Shore A to about 40 Shore A. In addition, the foot bed 51includes cushions 51C, which may comprise an integral part of one ormore sections 52 (e.g., layers, etc.) of the foot bed 51, or which maybe applied to a surface 53 of the foot bed 51. The embodiment of footbed 51 illustrated by FIG. 8 includes an elongated, curved flexibleregion 51F that generally follows the path of the fundamentallongitudinal arch of the foot, and a lateral flexible region 51F locatedbeneath the fifth metatarsal (i.e., the small toe, or “pinkie toe”). Thecurved flexible region 51F may allow the foot to flex where it naturallywants to flex. The lateral flexible region 51F may provide forflexibility in the mid-stance and toe-off phases of a subject's gait. Aportion of the rigid region 51R adjacent to the curved flexible region51F may define an arch support that prevents the arch of the foot fromcollapsing. Cushions 51C may be provided on the arch support and beneaththe heel for comfort.

As another example, a first material may be used to form sections 52(e.g. layers or other adhered elements) of a majority of the customorthosis 50, while a second material (e.g., a softer material, etc.) maybe used to form a plurality of adjacent, mutually adhered sections 52(e.g., layers or other adhered elements) that define features (e.g.,cushioned areas, etc.) of the custom orthosis 50.

In embodiments wherein the custom orthosis 50 comprises only part of anorthosis, the custom orthosis may be assembled with one or more standardelements of the orthosis.

A system according to this disclosure may include a three-dimensionalscanner 10, at least one processing element 14 and an additivemanufacturing system 60, which may perform the above-disclosedfunctions. Additionally, such a system may include a component in whicha cast, or negative model, of a body part is obtained, as well as anassembly component, in which a custom orthosis 50 may be assembled withone or more standard orthosis elements to define a complete orthosis.

When additive manufacturing processes are used to fabricate a customorthosis 50, the labor-intensive processes of hand-forming a positivemodel and making an orthosis may from such a physical model beeliminated. Thus, the amount of time it takes to make a custom orthosismay be significantly reduced. In some embodiments, it may be possible toreduce the time it takes to make a custom orthosis from two weeks ormore to as little as three to five days.

In a specific embodiment, the foregoing processes may be used to formone or more surfaces of an ankle brace, such as that depicted by FIG. 9.The embodiment of ankle brace depicted by FIG. 9 includes an upperelement, which is configured to be positioned around an ankle and tohold the ankle brace in place, and a bottom element that comprises theembodiment of custom orthosis 50 shown in FIGS. 6 and 7. In someembodiments, the upper element may comprise an off-the-shelf componentthat may have a standard shape and one of a limited number (e.g., one,three, five, etc.) of standard sizes. The use of one or more standardcomponents in the manufacture of a custom (or at least partially custom)orthosis may decrease the amount of time required to make the orthosisand minimize the cost of a custom orthosis. In other embodiments,however, the disclosed processes may be used to fabricate two or morecomponents of an orthosis, such as both the upper element and the lowerelement of the depicted ankle brace.

Custom orthotic components may be desirable in a variety of situations,including those where a standard component will not fit a particularbody part (e.g., the contour on the bottom of a foot, etc.) in a desiredmanner, and the standard component cannot be adjusted in a manner thatwill provide the desired fit.

Although the foregoing description contains many specifics, these shouldnot be construed as limiting the scopes of the inventions recited by anyof the appended claims, but merely as providing information pertinent tosome specific embodiments that may fall within the scopes of theappended claims. Features from different embodiments may be employed incombination. In addition, other embodiments may also lie within thescopes of the appended claims. All additions to, deletions from andmodifications of the disclosed subject matter that fall within thescopes of the claims are to be embraced by the claims.

What is claimed:
 1. A method for fabricating a custom orthosis,comprising: generating, from three-dimensional data obtained from a bodypart, a digital negative model of the body part for which a customorthosis is to be made, the digital negative model including customsurface data corresponding to at least one surface of the body part;applying the digital negative model to a digital orthosis model toincorporate the custom surface data into a customizable area of thedigital orthosis model to create a custom digital orthosis model; andusing the custom digital orthosis model to directly fabricate at least aportion of the custom orthosis for use on the body part.
 2. The methodof claim 1, further comprising: scanning the body part for which thecustom orthosis is to be made to provide the three-dimensional data forgenerating the digital negative model.
 3. The method of claim 2, whereinscanning the body part comprises dynamically scanning the body part forwhich the custom orthosis is to be made to obtain a plurality of scansof the body part that correspond to a plurality of positions of the bodypart during movement of the body part.
 4. The method of claim 3, whereindynamically scanning the body part comprises dynamically scanning a footin a plurality of positions during walking or running.
 5. The method ofclaim 3, wherein dynamically scanning the body part comprisesdynamically scanning an ankle in a plurality of positions during walkingor running.
 6. The method of claim 3, wherein dynamically scanning thebody part comprises dynamically scanning a knee in a plurality ofpositions during walking or running.
 7. The method of claim 3, furthercomprising: analyzing data from the plurality of scans to identify atleast one location of the body part that is subject to unnaturallyexcessive motion during movement of the body part; and fabricating thecustom orthosis to: prevent the unnaturally excessive movement of the atleast one location of the body part; and enable natural movement ofunaffected locations of the body part.
 8. The method of claim 3, furthercomprising: analyzing data from the plurality of scans to identify atleast one location of the body part that is subject to unnaturallyrestricted motion during movement of the body part; and fabricating thecustom orthosis to: enable natural movement of the at least one locationof the body part.
 9. The method of claim 7, wherein fabricating thecustom orthosis includes fabricating the custom orthosis to include asurface with: at least one rigid region to prevent the unnaturallyexcessive movement; and a plurality of flexible regions to enable thenatural movement.
 10. The method of claim 9, wherein fabricating thecustom orthosis comprises fabricating the custom orthosis to include theat least one rigid region and the plurality of flexible regions in afoot bed of an orthosis for a foot.
 11. The method of claim 1, furthercomprising: forming a cast of the body part; and scanning the cast toprovide the three-dimensional data for generating the digital negativemodel.
 12. The method of claim 1, further comprising: forming a cast ofthe body part; forming a positive physical model of the body part; andscanning the positive physical model to provide the three-dimensionaldata for generating the digital negative model.
 13. The method of claim1, further comprising: applying at least one symbol to the digitalnegative model.
 14. The method of claim 1, further comprising:incorporating a modification corresponding to at least one symbol intothe digital negative model.
 15. The method of claim 14, whereinincorporating comprises incorporating a build-up, a recess or an area ofdifferent hardness into the digital negative model.
 16. The method ofclaim 1, wherein applying the digital negative model to the digitalorthosis model comprises applying the digital negative model to adigital orthosis model including at least one standard feature.
 17. Themethod of claim 1, wherein using the custom digital orthosis modelincludes separating the custom digital orthosis model into a pluralityof sections.
 18. The method of claim 17, wherein using the customdigital orthosis model to directly fabricate the custom orthosiscomprises sequentially defining a plurality of adjacent sections of thecustom orthosis, at least one section being formed adjacent to andadhered to a previously formed section of the custom orthosis.
 19. Themethod of claim 17, wherein using the custom digital orthosis model todirectly fabricate the custom orthosis comprises: fabricating a sectionof the custom orthosis; and fabricating a subsequent section in contactwith a previously formed section.
 20. The method of claim 19, whereinfabricating the subsequent section comprises fabricating a layer with arigid region comprising a rigid material and a flexible regioncomprising a flexible material.
 21. The method of claim 20, whereinfabricating the section comprises fabricating a layer with a rigidregion comprising a rigid material and a flexible region comprising aflexible material, the rigid region and the flexible region of thesubsequent section respectively at least partially superimposed with therigid region and the flexible region of the section.
 22. The method ofclaim 20, wherein fabricating the section and fabricating the subsequentsection comprise additive manufacturing.
 23. The method of claim 19,wherein fabricating the section and fabricating the subsequent sectioncomprise fabricating a plurality of at least partially superimposed,mutually adhered layers in a manner that imparts the custom orthosiswith substantially smooth surfaces.
 24. A custom orthosis, comprising: aplurality of at least partially superimposed, mutually adhered layers,each including at least one rigid region and at least one flexibleregion, adjacent, corresponding rigid regions in different layers of theplurality being at least partially superimposed relative to each other,adjacent, corresponding flexible regions in different layers of theplurality being at least partially superimposed relative to each other;and at least one surface configured to form fit to a body part of asubject, the at least one surface being defined by a plurality ofseparately defined, adjacent, integrated sections configured to impartthe custom orthosis with flexibility and strength, the at least onesurface including at least one rigid region and at least one flexibleregion defined by materials of different durometers in a same layer ofthe plurality of at least partially superimposed, mutually adheredlayers.
 25. The custom orthosis of claim 24, wherein the at least onesurface is a substantially smooth surface.
 26. The custom orthosis ofclaim 24, wherein the at least one rigid region and the at least oneflexible region are arranged to prevent unnaturally excessive movementof any portion of the body part while enabling normal movement of allportions of the body part.
 27. The custom orthosis of claim 24, whereinthe at least one rigid region of each layer of the plurality comprises amaterial having a durometer of about 90 Shore A and the at least oneflexible region of each layer of the plurality comprises a materialhaving a durometer of about 30 Shore A to about 40 Shore A.
 28. A customorthosis, comprising: at least one surface configured to form fit to abody part of a subject, the at least one surface being defined by aplurality of separately defined, adjacent, integrated sectionsconfigured to impart the custom orthosis with flexibility and strength,the surface including at least one rigid region and at least oneflexible region; and a cushioned area that includes a softer materialthan a hardness of a material that defines a majority of the customorthosis, the cushioned area and the majority of the custom orthosisboth including a plurality of separately defined, adjacent, integratedsections.
 29. A system for fabricating a custom orthosis, comprising: aphysical model generation component at which a physical model of a bodypart of a patient is made; and a custom orthosis manufacturing componentremote from the physical model generation component, the custom orthosismanufacturing component including: a scanner for obtaining, from thephysical model, three-dimensional surface contour data corresponding toa contour of at least one surface of a body part; a processing elementprogrammed to apply the three-dimensional surface contour data to adigital orthosis model to define a custom digital orthosis model; and anadditive manufacturing system configured to use the custom digitalorthosis model to fabricate a custom orthosis.
 30. The system of claim29, wherein the physical model comprises a cast providing a negativemodel of the body part for scanning by the scanner.
 31. The system ofclaim 29, further comprising: an assembly component for assembling thecustom orthosis with at least one standard orthosis element.
 32. Thesystem of claim 29, wherein the physical model generation componentcomprises a health care provider.
 33. The system of claim 32, whereinthe custom orthosis manufacturing component is configured to manufacturea custom orthosis within a day.
 34. The system of claim 29, wherein theadditive manufacturing system is configured to selectively use aplurality of different materials to fabricate the custom orthosis toinclude at least one surface with at least one rigid region and at leastone flexible region.
 35. The system of claim 34, wherein the additivemanufacturing system is configured to define at least one layer from aplurality of different materials having different durometers from oneanother.
 36. The system of claim 35, wherein the additive manufacturingsystem is configured to define: at least one rigid region of the atleast one layer from a material having a hardness of about 90 Shore A ormore; and at least one flexible region of the at least one layer from amaterial having a hardness of about 30 Shore A to about 40 Shore A.